Phase Ⅰ Clinical Study of Anti-CD52 Monoclonal Antibody in NHL and T-PLL

NCT05557903 | Unknown Phase 1 DMC

• 1 other identifier: RD04-CD52-V01
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I clinical study of multicenter, single-arm, open, non-randomized evaluation of recombinant humanized anti-CD52 monoclonal antibody in the NHL and T-PLL

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, T-Cell

Keywords

anti-CD52 monoclonal antibody; relapsed and refractory

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v5.0

  Adverse events that occurred during the entire study period were evaluated and graded according to NCI-CTCAE v5.0, and dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) were observed. Safety evaluation indexes include vital signs, physical examination, 12-lead electrocardiogram, echocardiography, clinical laboratory examination indexes (blood routine, blood biochemistry, urine routine, coagulation function, etc.), changes of ECOG physical fitness score, adverse events and serious adverse event, etc.

  6 weeks

Secondary Outcomes (15)

• Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（single administration）

  1 weeks

• Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（single administration）

  1 weeks

• Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（single administration）

  1 weeks

• Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（single administration）

  1 weeks

• Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（single administration）

  1 weeks

Study Arms (1)

Treatment Group of anti-CD52 monoclonal antibody

EXPERIMENTAL

safety and tolerability, pharmacokinetic characteristics and preliminary efficacy in the treatment of relapsed and refractory nhl (including cll/sll, pll, ptcl, diffuse large b-cell lymphoma, follicular cell lymphoma, mantle cell lymphoma, and marginal zone lymphoma) and initially treated t-pll of recombinant humanized anti-cd52 monoclonal antibody injection

Biological: Recombinant Humanized Anti-CD52 Monoclonal Antibody Injection

Interventions

Recombinant Humanized Anti-CD52 Monoclonal Antibody Injection BIOLOGICAL

Single dosing: DLT observation for 7 days after administration; Multiple dosing: 3times/weeks,12 times, 28 days of DLT observation

Also known as: Anti-CD52 Monoclonal Antibody

Treatment Group of anti-CD52 monoclonal antibody

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For Patients With Relapsed And Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma/Lymphoblastic Leukemia (CLL/SLL/PLL) And Initial Treated t-Lymphoblastic Leukemia ( InitialTreated T-PLL)
• Patients with CLL/SLL or PLL were confirmed by histopathological or flow immunotyping;
• Patients with indications for treatment according to iwCLL2018 criteria and determined by the investigator;
• Age from 18 to 70 (including boundary value), no gender limitation;
• ECOG physical condition score 0 \~ 2;
• Patients have measurable lesions (lymphadenopathy (maximum baseline diameter ≥1.5 cm), or hepatomegaly/splenomegaly due to CLL or PLL or peripheral tumor lymphocytes \>5×10E9/L);
• CLL/SLL patients are intolerant or resistant to previous BTK inhibitor treatment; Or newly treated patients with T-PLL; Or relapse-resistant PLL (relapse-resistant PLL is defined as disease progression following recent remission of treatment. Treatment-resistant disease was defined as failure to achieve ≥PR from the most recent treatment or disease progression within 6 months of the last treatment);
• Laboratory test results must meet the following requirements (no blood components, short-acting cell growth factor and other drugs are allowed within 7 days prior to laboratory test; Long-acting growth factor is not allowed within the first 14 days), and laboratory test results within 7 days before screening;
• Bone marrow function: Neutrophils ≥1×10E9/L, platelets ≥50×10E9/L, and hemoglobin ≥75g/L were observed without growth factor support treatment.
• Liver function: AST and ALT ≤2×ULN (no liver invasion); Alanine aminotransferase or/and aspartate aminotransferase ≤5×ULN (liver aggressor). Total bilirubin ≤2×ULN;
• Renal function: serum creatinine ≤2×ULN and creatinine clearance rate \> 50mL/min;
• Blood coagulation function: international standardized ratio (INR) ≤1.5×ULN and activated partial thrombin time (APTT) ≤1.5×ULN;
• Life expectancy \> 3 months;
• Fertile men and women of reproductive age are willing to take effective contraceptive measures from the signing of informed consent to 6 months after the last administration of the experimental drug; Women of childbearing age must have a negative blood pregnancy test no later than 7 days before the first trial drug is administered.
• Agreed to follow the experimental treatment plan and visit plan, voluntarily enrolled in the study, and signed written informed consent.

You may not qualify if:

• For Patients With Relapsed And Refractory CLL/SLL/PLL And Initial Treated T-PLL
• Central nervous system (CNS) or meningeal involvement or history of such involvement before enrollment;
• Received systemic steroid hormone (dose equivalent to prednisone ≥10mg/ day) and antitumor therapy within 7 days prior to initial administration of the study drug, chemotherapy, targeted therapy, radiotherapy or antibody therapy within 4 weeks or 5 half-lives, whichever is older; Failure to recover from AE associated with prior systemic antitumor therapy to nCI General Adverse Event Term version 5.0 (CT CAE Version 5.0) grade ≤1 (except hair loss);
• Autoimmune cytopenia with clinical manifestations;
• Have a history of active, known autoimmune deficiency, or other acquired, congenital immune deficiency diseases, or a history of organ transplantation;
• There was a history of other active malignant tumors within 2 years prior to the entry of the study, except for the following cases :(1) effectively controlled cervical cancer in situ; (2) effectively controlled local basal cell carcinoma of skin; (3) Other previous malignant tumors that have been clinically cured and have no clinical signs for ≥5 years;
• Currently has clinical significance of cardiovascular disease, activity, such as uncontrolled arrhythmias, uncontrolled hypertension, congestive heart failure, according to the New York heart association functional class determine any 3 or 4 heart disease, or a period of 6 months before screening history of myocardial infarction, or heart left ventricular ejection fraction \< 50%;
• Had active systemic infections (bacterial, fungal, viral, etc.) within 2 weeks prior to enrollment, including infections being treated with oral or intravenous antibiotics;
• Known patients with acute or chronic active hepatitis b (HBsAg positive and HBV DNA viral load ≥200IU/mL or ≥10E3 copy number /mL, other abnormal results will be determined by the investigator whether to add quantitative HBV DNA test or exclude); Acute or active hepatitis C (HCV antibody positive); And other acquired, congenital immunodeficiency diseases, including but not limited to HIV-infected persons; Or treponema pallidum antibody positive; Or CMV-DNA positive;
• Patients with or clinically suspected Richter's syndrome at the time of screening;
• Patients who received or received radiation therapy within the first 4 weeks of enrollment (except for treated bone marrow volume less than 10% and patients with evaluable lesions beyond the radiation report). Prior radioimmunotherapy within 3 months prior to initiation of the study drug;
• Are currently participating in an interventional clinical trial treatment, or have been treated with another clinical trial drug or device within 4 weeks prior to initial administration;
• Received any live virus vaccine or attenuated live vaccine within 3 months prior to enrollment;
• Prior allogeneic stem cell transplantation or autologous hematopoietic stem cell transplantation or any active graft-versus-host disease basis or immunosuppressant use within 21 days prior to initiation of investigational therapy;
• Known history of allergic diseases or severe allergies; Or is known to be allergic to protein preparations, biological agents, or any component of the test drug;

Sponsors & Collaborators

• Lanzhou Institute of Biological Products Co., Ltd: lead

Study Sites (1)

Jiangsu Provincial People's Hospital

Najing, Jiangsu, 210011, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, T-Cell; Recurrence

Interventions

Alemtuzumab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• jianyong Li

  Jiangsu Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yu xiaoge

CONTACT

025-68306360; jsphkj@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2022
• First Posted: September 28, 2022
• Study Start: December 20, 2021
• Primary Completion: December 30, 2022
• Study Completion: June 30, 2023
• Last Updated: September 28, 2022

Record last verified: 2022-02

Locations

CN (1)